Drug Element Q&A

What information should be included in the Structured Data Table of a Drug Product?

The following information should be included in the data elements section of SPL:

• Active ingredient(s) – name, strength
• Active moiety – name
• Inactive ingredient(s) – name and strength (if required in labeling)
• Drug product: Proprietary name and product code
• Drug product: Nonproprietary name
• Package type(s) [List of Terms]
• Quantity per package
• National Drug Code(s) (NDC)
• Drug Enforcement Administration (DEA) schedule.
• Dosage Form [List of Terms]
• Labeled route(s) of administration [List of Terms]
• Flavor [List of Terms]
• Imprinting characteristics (required for solid dosage forms)

References:
Structured Product Labeling Implementation Guide with Validation Procedures v1.0 (PDF))
See http://www.fda.gov/oc/datacouncil/spl.html for any updates to the Implementation Guide.

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Can I include a Color for non-solid (liquid) products?

Color can be used for a liquid formulation as well as a solid.